Home > EHR, FDA, meaningful use, research > FDA Workshop on Unique Device Identification in Health-Related Electronic Data Systems

FDA Workshop on Unique Device Identification in Health-Related Electronic Data Systems

On July 21, the Food and Drug Administration (FDA) announced a public workshop titled, “Unique Device Identification (UDI) for Postmarket Surveillance and Enforcement.”  The event will take place in Bethesda, Maryland on September 12-13.   FDA will also provide a webcast option for participation.

The general focus of the workshop will be the use of UDI in health-related electronic data systems, including EHRs, PHRs, device registries, etc.  The draft agenda, which does not yet include a speaker list, is currently available here.

The Federal Register notice indicates a September 5 registration deadline; however, the website for the event mentions that registrants should sign up by August 29.  I suspect an event like this will fill up rather quickly.

My expectation is that the workshop will focus mostly on personal health devices such as monitors and implants, and not so much on medical imaging related devices.  This was also the focus of an Office of the National Coordinator for HIT (ONC) HIT Standards Committee-Clinical Operations Workgroup discussion back in March 2011.

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Categories: EHR, FDA, meaningful use, research
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